BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM T2 PROX. HUM.

    MDR report key: 2699968 · Received August 7, 2012

    Report

    Report Number
    9610622-2012-00353
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    July 26, 2012
    Report Date
    July 26, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 1832-1045S, PROXIMAL HUMERAL NAIL, CANNULATED, RIGHT T2 PROX. HUM. 8X150MM, LOT # K290516; 1806-2025, NAIL ADAPTER T2 PROX. HUM., LOT # UNK; 1806-0163, NAIL HOLDING SCREW, HUMERUS T2 HUMERUS 10MM, LOT # UNK; 1806-0180, TISSUE PROTECTION SLEEVE, SHORT T2 TIBIA 9MM, LOT #UNK; 1806-0210 DRILL SLEEVE, SHORT T2 TIBIA <5MM, LOT # UNK; 1806-3545, DRILL, TRI-FLAT T2 HUMERUS 3,5X230 MM, LOT# UNK; 1806-2030, NUT T2 PROX. HUM., LOT# UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2012, T2PH OPERATION WAS PERFORMED. WHEN THE SURGEON CHECKED THAT THE FUNCTION OF THE DEVICE WAS NORMAL, THE DRILL CONTACTED THE DISTAL HOLE OF THE NAIL. ALTHOUGH HE RECONNECTED THE NAIL, THE STATE DID NOT CHANGE. HE DRILLED TO THE DISTAL HOLE OF THE NAIL WITH FREE HAND TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM T2 PROX. HUM. INSTRUMENT LXH STRYKER TRAUMA GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other